– New Oral Pellet Formulation Enables
Treatment in Early Childhood with Pangenotypic, Panfibrotic
Regimen –
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the
U.S. Food and Drug Administration (FDA) has approved an expansion
of the pediatric indication of Epclusa® (sofosbuvir/velpatasvir)
for the treatment of chronic hepatitis C virus (HCV) to now include
children as young as 3 years of age, regardless of HCV genotype or
liver disease severity. The FDA approved a New Drug Application
(NDA) for two strengths of an oral pellet formulation of Epclusa
(sofosbuvir 200 mg/velpatasvir 50 mg and sofosbuvir 150
mg/velpatasvir 37.5 mg) developed for use by younger children who
cannot swallow tablets. The recommended dosage of Epclusa in
children ages 3 years and older is based on weight.
Treatment with Epclusa for 12 weeks was approved in patients
without cirrhosis or with compensated cirrhosis (Child-Pugh A), and
in combination with ribavirin (RBV) for patients with decompensated
cirrhosis (Child-Pugh B or C). Sofosbuvir/velpatasvir is the only
protease inhibitor-free, pangenotypic HCV regimen approved for
patients as young as 3 years of age.
In the United States, as of 2018 there were approximately 35,300
to 60,500 children living with HCV and incidence has been on the
rise. Mother-to-child transmission, the most common cause of HCV
infection in children, increased 161% from 2009 to 2017, with
intravenous drug use representing the primary driver of HCV
infection among women of childbearing age.
“Gilead remains steadfast in our commitment to supporting HCV
elimination. Today’s decision by the FDA represents important
progress toward that goal by expanding more cure options for
children living with HCV,” said Merdad Parsey, MD, PhD, Chief
Medical Officer, Gilead Sciences. “This approval adds to the robust
clinical evidence supporting the safety and efficacy of Epclusa
across a broad set of patients, including those with end-stage
renal disease and all stages of fibrosis.”
The approval of Epclusa for children as young as 3 years of age
is based on data from a Phase 2, open-label clinical trial that
enrolled 41 children 3 years to less than 6 years of age to be
treated with Epclusa for 12 weeks. At 12 weeks after treatment
completion, Epclusa achieved a sustained virologic response (SVR12)
or cure rate of 83% (34/41) among all patients, 88% (28/32) in
children with HCV genotype 1, 50% (3/6) in children with HCV
genotype 2, and 100% in children with HCV genotype 3 (2/2) and HCV
genotype 4 (1/1). Of the seven patients who did not achieve cure,
all discontinued treatment within one to 20 days of starting
treatment.
The safety profile of Epclusa in children 3 to less than 6 years
of age treated was generally consistent with that observed in
clinical trials in adults. Vomiting and product use issue (spitting
up the drug) were reported in 15% and 10% of subjects,
respectively; these adverse reactions were mild (Grade 1 or 2) and
led to treatment discontinuation in 5 (12%) subjects.
Please see below for the U.S. Indication and Important Safety
Information, including BOXED WARNING, for Epclusa.
“Treating pediatric HCV remains an important public health
priority. The Phase 2 clinical trial results previously showed that
this medication was effective in treating many HCV-infected
patients, regardless of genotype,” said Karen Murray, MD, Chair of
Cleveland Clinic Children’s and lead investigator of the pediatric
study. “Now, the expanded approval and oral pellet formulation
offer new treatment strategies in younger patients with HCV.”
U.S. IMPORTANT SAFETY INFORMATION AND INDICATION FOR THE USE
OF EPCLUSA
BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN
HCV/HBV COINFECTED PATIENTS
Test all patients for evidence of current or prior hepatitis
B virus (HBV) infection before initiating treatment with EPCLUSA.
HBV reactivation has been reported in HCV/HBV coinfected patients
who were undergoing or had completed treatment with HCV direct
acting antivirals (DAAs) and were not receiving HBV antiviral
therapy. Some cases have resulted in fulminant hepatitis, hepatic
failure, and death. Cases have been reported in patients who are
HBsAg positive, in patients with serologic evidence of resolved
HBV, and also in patients receiving certain immunosuppressant or
chemotherapeutic agents; the risk of HBV reactivation associated
with treatment with HCV DAAs may be increased in patients taking
these other agents. Monitor HCV/HBV coinfected patients for
hepatitis flare or HBV reactivation during HCV treatment and
post-treatment follow-up. Initiate appropriate patient management
for HBV infection as clinically indicated.
Contraindications
- If EPCLUSA is used in combination with ribavirin (RBV), all
contraindications, warnings and precautions, in particular
pregnancy avoidance, and adverse reactions to RBV also apply. Refer
to RBV prescribing information.
Warnings and Precautions
- Serious Symptomatic Bradycardia When Coadministered with
Amiodarone: Amiodarone is not recommended for use with EPCLUSA
due to the risk of symptomatic bradycardia, particularly in
patients also taking beta blockers or with underlying cardiac
comorbidities and/or with advanced liver disease. A fatal cardiac
arrest was reported in a patient taking amiodarone who was
coadministered a sofosbuvir containing regimen. In patients without
alternative, viable treatment options, cardiac monitoring is
recommended. Patients should seek immediate medical evaluation if
they develop signs or symptoms of bradycardia.
- Risk of Reduced Therapeutic Effect Due to Use with P-gp
Inducers and/or Moderate to Strong Inducers of CYP2B6, CYP2C8 or
CYP3A4: Rifampin, St. John’s wort and carbamazepine are not
recommended for use with EPCLUSA as they may significantly decrease
sofosbuvir and/or velpatasvir plasma concentrations.
Adverse Reactions
- The most common adverse reactions (≥10%, all grades) with
EPCLUSA in adults and pediatric patients 6 years of age and older
were headache and fatigue; and when used with RBV in adults with
decompensated cirrhosis were fatigue, anemia, nausea, headache,
insomnia and diarrhea. The most common adverse reactions (≥10%,
grade 1 or 2) in pediatric patients less than 6 years of age were
vomiting and spitting up the drug.
Drug Interactions
- Coadministration of EPCLUSA is not recommended with topotecan
due to increased concentrations of topotecan.
- Coadministration of EPCLUSA is not recommended with proton-pump
inhibitors, phenobarbital, phenytoin, rifabutin, rifapentine,
efavirenz, and tipranavir/ritonavir due to decreased concentrations
of sofosbuvir and/or velpatasvir.
Consult the full Prescribing Information for EPCLUSA for more
information on potentially significant drug interactions, including
clinical comments.
INDICATION
EPCLUSA is indicated for the treatment of adult and pediatric
patients 3 years of age and older with chronic hepatitis C virus
genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with
compensated cirrhosis and in combination with ribavirin for those
with decompensated cirrhosis.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has
pursued and achieved breakthroughs in medicine for more than three
decades, with the goal of creating a healthier world for all
people. The company is committed to advancing innovative medicines
to prevent and treat life-threatening diseases, including HIV,
viral hepatitis and cancer. Gilead operates in more than 35
countries worldwide, with headquarters in Foster City,
California.
Forward-Looking
Statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including the risk that physicians may not see the benefits of
prescribing Epclusa for the treatment of chronic HCV infection and
the possibility of unfavorable results from ongoing and additional
clinical studies involving Epclusa. These and other risks,
uncertainties and other factors are described in detail in Gilead’s
Quarterly Report on Form 10-Q for the quarter ended March 31, 2021,
as filed with the U.S. Securities and Exchange Commission. These
risks, uncertainties and other factors could cause actual results
to differ materially from those referred to in the forward-looking
statements. All statements other than statements of historical fact
are statements that could be deemed forward-looking statements.
Investors are cautioned that any such forward-looking statements
are not guarantees of future performance and involve risks and
uncertainties and are cautioned not to place undue reliance on
these forward-looking statements. All forward-looking statements
are based on information currently available to Gilead, and Gilead
assumes no obligation and disclaims any intent to update any such
forward-looking statements.
U.S. Prescribing Information for Epclusa,
including BOXED WARNING, is available at www.gilead.com.
Epclusa is a registered trademark of Gilead
Sciences, Inc., or its related companies.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210610005958/en/
Jacquie Ross, Investors (650) 358-1054
Nat Sillin, Media (650) 866-9374
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Apr 2024 to May 2024
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From May 2023 to May 2024